COOPER VISION I/A SYSTEM III MODEL 1500— 510(k) K822220
Substantially EquivalentCooperVision, Inc.
FDA 510(k) clearance K822220 for COOPER VISION I/A SYSTEM III MODEL 1500, Substantially Equivalent on 1982-10-06. Applicant: CooperVision, Inc.. Device class: 2.
Clearance details
- Applicant
- CooperVision, Inc.
- Product code
- Code HQE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4150
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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Adverse events under product code HQE
product code HQE- Injury
- 156
- Malfunction
- 565
- Total
- 721
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.